Medical Device Quality Control Technologist

Job Description This QC Lab Technician role supports process and product quality testing by preparing equipment, samples, and materials for submission to external laboratories for further analysis. The position combines hands-on laboratory work, cleanroom environmental monitoring, and detailed documentation to ensure products meet stringent quality and regulatory standards. You will work closely with production, quality, and third-party labs while contributing to a collaborative, training-focused culture with opportunities for growth within the Quality function.

Responsibilities Collect, prepare, and submit samples to various laboratories for further analysis, ensuring proper labeling, documentation, and chain-of-custody. Verify and analyze test results from internal and external laboratories, escalating any out-of-specification findings according to procedures. Prepare and mix chemical formulations for production and manufacturing use, following established Standard Operating Procedures (SOPs).

Perform in-process quality control tasks to support ongoing manufacturing operations and ensure products meet defined specifications. Maintain maintenance records for all laboratory and quality control equipment, ensuring equipment remains calibrated and in good working order. Perform environmental monitoring of cleanrooms, including humidity and temperature checks, and ensuring pest control measures are in place and documented.

Conduct daily pre-operational quality control checks of passivation chemistry to confirm readiness for production. Perform package visual inspections and conduct seal strength and integrity testing on pouches and sterile seals. Use measurement equipment such as micrometers, calipers, and rulers to verify dimensional and quality attributes. Review sterilization certificates to determine whether product can be fully released in accordance with quality requirements.

Review lot history records (LHRs) for completeness, accuracy, and compliance with quality system requirements. Maintain accurate, detailed records of all laboratory activities, test results, and inspections in accordance with quality documentation standards. Support quality control investigations and corrective and preventive actions (CAPAs), including gathering data, documenting findings, and implementing approved actions.

Verify that quality control measurements are accurate and ensure results are documented with strong attention to detail. Ensure inspections are completed on time and aligned with priorities and production schedules, helping to prevent delays in manufacturing and product release. Review manufacturing records, including sterile processing data, test results, certifications, labeling, and paperwork to ensure compliance with specifications and quality system requirements.

Partner with third-party laboratories to coordinate testing, clarify requirements, and ensure timely receipt and review of results. Enter, review, and manage data in computer systems for quality records, test results, and reports, dedicating approximately half of the role to computer-based work. Support a culture of quality by speaking up when something is out of scope or not aligned with procedures, and by consistently following SOPs.

Essential Skills Bachelor’s degree in a science discipline. At least 6 months of experience in environmental monitoring and/or sterilization activities. Hands-on experience with environmental monitoring in cleanrooms, including humidity and temperature monitoring and awareness of pest control measures. Experience performing or supporting microbiological testing such as bioburden and plating. Experience in quality control or quality assurance within a laboratory or manufacturing environment.

Ability to follow Standard Operating Procedures (SOPs) consistently, as verified by references. Demonstrated commitment to quality, including a willingness to speak up when something is out of scope or non-compliant. Ability to perform in-process qua